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New treatment option for Colorectal Cancer Metastatic
Official title Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06763029
What this study is testing
What is Irinotecan liposomes combined with cetuximab + vermofenib?
Irinotecan liposomes combined with cetuximab + vermofenib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
Also referred to as Irinotecan liposomes+VC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Efficacy and safety of irinotecan liposomes combined with cetuximab + vermofenib in first-line failure of advanced RAS wild /BRAF mutated colorectal cancer, Exploratory analysis of biomarkers (including but not limited to ctDNA, immune microenvironment indicators, tumor mutation load, lymphocyte subsets, cytokines, gut microbes, and others) in relation to efficacy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- at least 18 years of age;
- Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;
- Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil...
- At least one measurable lesion according to RECIST v1.1;
- ECOG score is 0\~2;
You likely can't join if
- Patients who have previously received BRAF inhibitors or irinotecan liposomes;
- Proven allergic to the test drug and/or its excipients;
- symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
- Acute or subacute intestinal obstruction or chronic inflammatory bowel disease;
- have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and...
- Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;
See the full eligibility criteria
- at least 18 years of age;
- Colorectal adenocarcinoma was confirmed by histological or cytopathological examination, and RAS wild /BRAF V600E mutation was detected by PCR or NGS;
- Failure or intolerance of standard first-line treatment. First-line regimens including oxaliplatin and/or irinotecan in combination with fluorouracil in patients with MSS; For BRAF V600E mutated patients with MSI-H...
- At least one measurable lesion according to RECIST v1.1;
- ECOG score is 0\~2;
- Good bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L, white blood cells (WBC) ≥3.0×109/L, albumin (ALB) ≥32 g/L, and no bleeding tendency; ② AST, ALT...
- Expected survival ≥3 months;
- Can understand the situation of this study, patients and (or) legal representatives voluntarily agree to participate in this study and sign informed consent.
- Patients who have previously received BRAF inhibitors or irinotecan liposomes;
- Proven allergic to the test drug and/or its excipients;
- symptomatic, untreated brain metastases or meningeal metastases that fail to achieve clinical stability;
- Acute or subacute intestinal obstruction or chronic inflammatory bowel disease;
- have had other malignant tumors within the past 5 years or currently, except for cured cervical carcinoma in situ, uterine carcinoma in situ and non-melanoma skin cancer;
- Pregnant or lactating female patients, patients of childbearing age who refuse to accept contraceptive measures;
- Patients considered by the investigator to be unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.